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Positive Therapy for Autonomic Function & Mood in ICD Patients (PAM-ICD)

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ClinicalTrials.gov Identifier: NCT02088619
Recruitment Status : Completed
First Posted : March 17, 2014
Last Update Posted : October 2, 2017
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Medical University of South Carolina

Tracking Information
First Submitted Date  ICMJE February 18, 2014
First Posted Date  ICMJE March 17, 2014
Last Update Posted Date October 2, 2017
Actual Study Start Date  ICMJE July 2014
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2014)
  • Frequency of arrhythmias between baseline and 3-months [ Time Frame: 3-months ]
    Total arrhythmia frequencies between baseline and 3-months will be the sum of non-sustained ventricular tachycardia (NSVT) detected on the Holter ( ≥6 beats, at >120 beats per minute [BPM] ) plus arrhythmias detected by the ICD
  • Frequency of arrhythmias between 3-months and 9-months [ Time Frame: 9-months ]
    Total arrhythmia frequencies between 3-months and 9-months will be the sum of non-sustained ventricular tachycardia (NSVT) detected on the Holter ( ≥6 beats, at >120 BPM ) plus arrhythmias detected by the ICD
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2014)
  • Frequency of ICD therapies between baseline and 3-months [ Time Frame: 3-months ]
    Obtained from ICD interrogation reports from recording between baseline and 3-months
  • Change in High Frequency heart rate variability (HF-HRV) between baseline and 3-months [ Time Frame: 3-months ]
    Index of parasympathetic activity; obtained from 24-hour Holter recording
  • Frequency of ICD therapies between 3-months and 9-months [ Time Frame: 9-months ]
    Obtained from ICD interrogation reports between 3- and 9-months
  • Change in High Frequency heart rate variability (HF-HRV) between 3- and 9-months [ Time Frame: 9-months ]
    Index of parasympathetic activity; obtained from 24-hour Holter recording
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 13, 2014)
  • Florida Shock Anxiety Scale [ Time Frame: 3 months ]
  • Florida Patient Acceptance Scale [ Time Frame: 3-months ]
  • Emotions Questionnaire [ Time Frame: 3-months ]
  • Center for Epidemiologic Studies - Depression Scale (CES-D) [ Time Frame: 3-months ]
  • State Trait Anxiety Inventory (STAI) [ Time Frame: 3-months ]
  • Life Orientation Test - Revised (LOT-R) [ Time Frame: 3-months ]
  • Positive and Negative Affect Schedule (PANAS) [ Time Frame: 3-months ]
  • Satisfaction with Life Scale (SWLS) [ Time Frame: 3-months ]
  • Quality of Life Inventory (QOLI) [ Time Frame: 3-months ]
  • Short-Form Health Survey-36 (SF-36) [ Time Frame: 3-months ]
  • Minnesota Living with Heart Failure Questionnaire (MLHFQ) [ Time Frame: 3-months ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Positive Therapy for Autonomic Function & Mood in ICD Patients
Official Title  ICMJE Positive Psychotherapy to Improve Autonomic Function and Mood in ICD Patients
Brief Summary The purpose of this 2-group randomized clinical trial is to: 1) examine the feasibility and acceptability of a 3-month positive-emotion focused therapy (Quality of Life Therapy) modified specifically for patients with implantable cardioverter defibrillator (ICD); and 2) obtain estimates of effect size for QOLT compared to Heart Healthy Education on the changes in arrhythmia frequency and biomarkers of autonomic function, as well as changes in emotion, mood, and well-being across time (baseline, 3 & 9-months). It is hypothesized that the QOLT will promote improvements in autonomic function, reduced arrhythmia frequency, and improved psychological well-being.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Ventricular Arrhythmia
  • Implantable Cardioverter Defibrillator
Intervention  ICMJE
  • Behavioral: Quality of Life Therapy (QOLT)
  • Behavioral: Heart Healthy Education (HHE)
Study Arms  ICMJE
  • Experimental: Quality of Life Therapy (QOLT)
    Positive emotion-focused cognitive behavioral psychotherapy
    Intervention: Behavioral: Quality of Life Therapy (QOLT)
  • Active Comparator: Heart Healthy Education (HHE)
    Heart healthy education program
    Intervention: Behavioral: Heart Healthy Education (HHE)
Publications * Frisch M. Quality of Life Therapy; Applying a Life Satisfaction Approach to Positive Psychology and Cognitive Therapy. Hobokon, NJ: John Wiley & Sons, Inc.; 2006.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 1, 2016)
29
Original Estimated Enrollment  ICMJE
 (submitted: March 13, 2014)
60
Actual Study Completion Date  ICMJE January 2017
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Adult men and women (≥18 years of age) who have received an ICD for primary or secondary prevention of sudden cardiac death. All patients will have systolic left ventricular dysfunction due to coronary disease or nonischemic cardiomyopathy. There is no requirement for time since implant;
  2. Score ≥5 on the Hospital Anxiety and Depression Scale (HADS) anxiety or depression scales;
  3. Able to read and write English
  4. Able to commit to the 3-month QOLT/HHE program and 3 assessments over a 9-month duration.

Exclusion Criteria:

  1. >5% atrial or ventricular pacing;
  2. Sinus node dysfunction;
  3. Persistent and permanent atrial fibrillation (AF) (h/o of paroxysmal AF will be allowed).
  4. Long QT syndrome; and other channelopathies such as Brugada syndrome;
  5. Hypertrophic cardiomyopathy;
  6. Neurocognitive or cognitive impairments;
  7. Severe psychopathology that warrants intensive treatment;
  8. Participation in another research trial; and
  9. Currently in psychological or psychiatric treatment.
  10. Current psychotropic and cardiac medication prescriptions and usage need to be stable (i.e., no change in type or dosage) for 3-months prior to study enrollment.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02088619
Other Study ID Numbers  ICMJE Pro00028869
1R34HL107733-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medical University of South Carolina
Study Sponsor  ICMJE Medical University of South Carolina
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Eva R Serber, PhD Medical University of South Carolina
PRS Account Medical University of South Carolina
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP